The Medicines for Human Use (Clinical Trials) Regulations 2004

1.—(1) Where the licensing authority are notified of the sponsor’s wish to make representations in accordance with regulation 26(1) or 31(7) the authority shall afford an opportunity for the sponsor to make written or oral representations to the appropriate committee or, if for the time being there is no such committee, the Medicines Commission.

(2) After considering the representations, the appropriate committee or the Medicines Commission shall report their findings and advice, and the reasons for their advice, to the licensing authority.

(3) In the case of a decision not to accept a request for authorisation or an amendment to the clinical trial authorisation, the licensing authority shall, after considering the report of the appropriate committee or the Commission—

(a) confirm that they have grounds for not accepting the request or amendment; or

(b) accept the request for authorisation or amendment to the clinical trial authorisation, subject to such conditions as the licensing authority may consider appropriate.

(4) In the case of a decision to impose a condition following a request for authorisation or notice of amendment, the licensing authority shall, after considering the report of the appropriate committee or the Commission—

(a) confirm their decision; or

(b) remove or alter the condition in question.

(5) In the case of a notice to suspend or terminate a trial, the licensing authority shall, after considering the report of the appropriate committee or the Commission, confirm or revoke the notice.

(6) The licensing authority shall give notice to the sponsor of—

(a) the findings and advice of the appropriate committee or the Medicines Commission and the reasons for it; and

(b) their decision in accordance with sub-paragraphs (3), (4) or (5).